Trial · NCT06581328
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14 | At Week 14 | PRO-2 remission is defined as 7-day average of very soft or liquid stool frequency (SF) less than and equal to (\<=) 2.8, 7-day average of abdominal pain (AP) score \<= 1.0, and neither worse than baseline. |
| Primary | Percentage of UC Participants With PRO-2 Remission at Week 14 | At Week 14 | PRO-2 remission is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1. |
| Secondary | Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52 | At Weeks 6 and 52 | PRO-2 remission for CD participants is defined as 7-day average of very soft or liquid SF \<= 2.8, 7-day average of AP score \<= 1.0, and neither worse than baseline. PRO-2 remission for UC participants is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1. |
| Secondary | Percentage of CD and UC Participants With Clinical Response at Weeks 6, 14, and 52 | At Weeks 6, 14, and 52 | CD clinical response is defined as greater than and equal to (\>=) 100 points decrease from baseline in CDAI score. UC clinical response is defined as reduction in complete Mayo score of \>=3 points and \>=30 percent (%) from baseline with an accompanying decrease in rectal bleeding sub-score of \>=1 point or absolute rectal bleeding sub-score of \<=1 point or an absolute rectal bleeding sub-score of \<=1 point, or a reduction in partial Mayo score of \>=2 points and \>=25% from baseline, if complete Mayo score was not performed at visit. |
| Secondary | Percentage of CD Participants With Endoscopic Response at Week 52 | At Week 52 | Endoscopic response is defined as a \>=50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 endoscopic variables: the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing. |
| Secondary | Percentage of CD Participants Achieving Endoscopic Remission at Week 52 | At Week 52 | Endoscopic remission as per SES-CD is defined as a SES-CD score of 0 to 4, with no individual sub-score greater than 1. SES-CD evaluates 4 endoscopic variables: the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing. |
| Secondary | Percentage of UC Participants With Improvement of Endoscopic Appearance of the Mucosa at Week 52 | At Week 52 | Improvement of endoscopic appearance of the mucosa is defined as Modified Mayo endoscopic sub-score (MMES) of 0 or 1. |
| Secondary | Percentage of UC Participants With Endoscopic Remission at Week 52 | At Week 52 | Endoscopic remission is defined as a centrally read complete Mayo endoscopy sub-score of 0. |
| Secondary | Percentage of CD and UC Participants With Clinical Remission at Weeks 6, 14, and 52 | At Weeks 6, 14, and 52 | Clinical Remission for CD is defined as a CDAI \<150 point. Clinical remission for UC is defined as complete MS of \<=2 points and no participant sub-score greater than (\>) 1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, physician's global assessment \[PGA\]) score of \<=2 and no individual sub-score \>1. |
| Secondary | Percentage of CD and UC Participants With Clinical Remission at Week 52 | At Week 52 | Clinical remission for CD is defined as a CDAI \<150 point. Clinical remission for UC is defined as complete MS of \<=2 points and no participant sub-score \>1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, PGA) score of \<=2 and no individual sub-score \>1. Percentage of CD and UC participants with clinical remission at Week 52, among those participants who achieved clinical remission at Week 6 and 14 will be reported. |
| Secondary | Change From Baseline in C-reactive Protein (CRP) levels of CD and UC Participants at Weeks 6, 14, 26, and 52 | Baseline, Weeks 6, 14, 26, and 52 | Change from baseline in CRP levels of CD and UC participants at Weeks 6, 14, 26, and 52 will be reported. |
| Secondary | Change From Baseline in Fecal Calprotectin Concentrations of CD and UC participants at Weeks 6, 14, and 52 | Baseline, Weeks 6, 14, and 52 | Change from baseline in fecal calprotectin concentrations of CD and UC participants at Weeks 6, 14, and 52 will be reported. |
| Secondary | Percentage of CD and UC Participants With Serious Infections | Up to end of study (up to 72 weeks) | Percentage of CD and UC participants with serious infections will be reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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